The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.

The consent decree restrains Ocean Harvest from preparing, packing, or distributing seafood until the company complies with the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The company also cannot prepare, pack or distribute seafood until it complies with the FDA’s current Good Manufacturing Practice regulations.

HACCP is a science-based system of preventive controls for seafood safety that commercial seafood processors can use to identify and control potential food safety hazards. The FDA seafood HACCP program was designed to increase the margin of safety for U.S. consumers and to reduce illnesses to the lowest possible levels in seafood products.

"The FDA is committed to reducing health risks for consumers of seafood products,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Ocean Harvest must meet the necessary requirements to ensure that their food is safe or it will not be able to process or distribute their products."

Ocean Harvest has an extensive history of operating under insanitary conditions and violating the seafood HACCP regulations. During the FDA’s most recent inspection of the company’s processing facility, investigators found that Ocean Harvest failed to implement adequate HACCP plans for the raw fresh fish intended for sale to sushi restaurants and failed to properly clean and sanitize equipment used to process fresh fish.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.